Director, Quality Assurance and Compliance ID-1062

BrainChild Bio is seeking to hire a Director, Quality Assurance and Compliance. The role will be responsible for leading the development and implementation of the quality management system at BrainChild Bio and ensuring compliance with GxP (i.e., GLP, GCP, GMP) standards and regulations.  This role involves managing relationships with internal cross-functional partners and vendors, oversight of training and compliance, and readiness for regulatory inspections, while providing expert guidance on quality matters within the biotech industry. The ideal candidate will bring deep subject matter expertise with a strategic, solutions-oriented mindset to partner with our cross-functional teams.  They are someone who seeks out opportunities to build something from scratch, aligning with the broader company strategy and vision, and ultimately holds the company to the highest standards of compliance.   

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Responsibilities: 

 

• Design, develop and implement overall GxP Quality Assurance and Compliance strategy and vision for BrainChild Bio
• Lead efforts to author, review, and approve all GxP quality documents
• Develop, implement, and manage the continuous improvement of robust quality management systems, including vendor management, deviation management, change control, CAPAs, and risk management,  
• Ensure compliance for internal and external activities with all applicable GxP regulations, (including GMP, GCP, and GLP), in collaboration with relevant SMEs and cross-functional leaders
• Establish and implement key quality system metrics, analytics, and reports to proactively identify and address issues
• Oversee the development and implementation of all relevant training programs to ensure staff are knowledgeable about GxP requirements and quality standards
• Deliver Quality guidance to BrainChild Bio product program teams during development and commercialization
• Provide leadership and guidance to teams on inspection readiness, including hosting and participating in regulatory inspections
• Provide appropriate oversight of all vendors, including CDMOs and CROs, to ensure regulatory compliance, 
• Facilitate routine Quality Management Reviews with senior leadership

 

Qualifications: 

 

• 12+ years of experience in the biotech/cell therapy industry 
• 5+ years in a leadership role 
• Extensive knowledge and application of GxP regulatory requirements and industry practices 
• Excellent communication skills and robust project management skills 
• History of success managing inspections performed by regulatory authorities a plus 
• Ability to deliver in a fast paced, small company environment and adjust workload based on shifting priorities and needs